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American Pediatric Society & Society for Pediatric Research Public Policy Council |
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April 2009 Legislative Report |
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OVERVIEWThe first session of the 111th Congress officially convened on January 6, 2009. Congress and the new administration are faced with many critical child and adolescent health issues such as passing the FY 2010 Congressional Budget Resolution, passing 12 appropriations bills to fund the federal government for next year, including funding Children’s Hospital GME program, health professions education and training (Title VII), community health centers, the National Institutes of Health, the National Children’s Study, the Centers for Disease Control and Prevention, and the Agency for Healthcare Quality and Research to name just a few. In addition, countless other bills such as the Pediatric Research Consortia Establishment Act, a tobacco regulation bill, an under-age drinking bill and many others also need to be passed by Congress. The first two months of the new Administration have been very exciting for the pediatric and adolescent medicine community including two important legislative victories. The first is the reauthorization of the Child Health Insurance Program (CHIP) signed by President Obama on February 4th. The second victory was the signing of the economic stimulus legislation - American Recovery and Reinvestment Act - that included increased funding for several programs and agencies that impact children and adolescents including the National Institutes of Health, the Agency for Healthcare Research and Quality, additional funding for immunizations, comparative effectiveness research, health professions training, the National Health Service Corps, as well as additional funding for FMAP – Federal Medical Assistance Percentages - and Health Information Technology. The following is a summary of federal legislative and regulatory actions of interest to the pediatric academic community. We hope that this information will assist you in your advocacy during the months ahead. We encourage you to share this information with your colleagues. The report includes information on the following issues:
PEDIATRIC RESEARCH
NIH Transition Team - Obama-Biden Administration: The Public Policy Council, working with the chair of the American Academy of Pediatrics Committee on Pediatric Research, provided an outline of pediatric research issues and interests important to the pediatric community to the NIH Transition Team for the Obama - Biden Administration. The focus of our comments were: the importance of including children in clinical research, reviewing the current policy guidelines for inclusion of children in clinical research and the need for an enhanced commitment by NIH to include children in research. Although a formal meeting with the NIH Transition Team was not feasible because of scheduling conflicts the information provided was acknowledge, in an informal discussion with members of the transition team, to be very helpful for the new Administration preparing its agenda for HHS and NIH in particular. Appropriations: Under the FY 2009 omnibus appropriations bill - the NIH is funded at $30.3 billion, an increase of $938 million or 3.2% above FY 2008. The proposed FY 2010 funding level recommendation from the NIH advocacy community is at least an increase of 7% increase above current levels. Economic Stimulus -2009 - 2010: In very exciting news, the pediatric academic societies working together with the Ad Hoc Group on Medical Research Funding, an umbrella coalition with over 300 organizations, supported additional funding in the stimulus package. Our collective efforts resulted in $10.4 billion for the NIH to be available until September 30, 2010. In a meeting held on February 18, with over 200 representatives from the scientific, medical and patient advocacy community, Acting NIH Director Raynard Kington, MD, PhD described the legislative allocation of the $10.4 billion. It includes:
Dr. Kington repeatedly emphasized that these dollars must be obligated within two years and if a researcher or institution could not spend the funds in that period of time they should not apply. He also outlined that the intent is to allocate the dollars through the peer review process based on three “big buckets” – RO1 and related mechanisms, supplements to existing grants and the new NIH challenge grants. The NIH has been sending out regular notices on the availability of funding. Most of the information can be found on the NIH website – http://www.nih.gov/recovery/index.htm New National Children’s Study Centers (NCS): Last October, the NCS announced the 25 new Study Centers that will manage operations in approximately 30 additional locations of the National Children's Study. Mike Genel, MD, an immediate past member of the NCS advisory council and chair of the Public Policy Council, at the request of the Academy, represented the pediatric community at this teleconference briefing. The newly-awarded Study Centers were selected from a pool of applicants assessed through a competitive process. This announcement builds on the momentum of earlier major Study milestones, including the release of the Study Plan and Study locations in 2004, the establishment in 2005 of the first 7 Study Centers, referred to as Vanguard Centers, and the announcement of 22 new Study Centers in 2007. In January, the NCS initiated field work for the pilot/feasibility study in two of the seven Vanguard locations – Queens, NY and Duplin, NC. The remainder will be included later in the year.
Pediatric Research
Consortia Establishment Act (S.353/ H.R. 758) Agency for Healthcare Research and Quality Appropriations: Working with the Friends of AHRQ, the pediatric community’s request is $405 million for FY 2010, with a goal of $500 million within the next few years. This is based on the slight boost in funding for FY 2009 to $372 million. AHRQ’s Effective Health Care Program will also receive a significant boost in funding of approximately $300 million from the economic stimulus package. Although there was some interest expressed by the Senate Health, Education, Labor and Pensions Committee (HELP) on the reauthorization of AHRQ, no action was taken in the 110th Congress but we do anticipate some renewed interest in the 111th Congress.
GME Financing for Children’s Hospitals (CHGME)
Appropriations: In conjunction with the Academy the
Public Policy Council members continue its collaboration
with the leadership of the National Association of
Children’s Hospitals (NACH) to urge the House and Senate
Appropriations Committees to include funding for the CHGME
at the authorized level of $330 million in FY 2010. The
CHGME is funded for the remainder of the fiscal year at $310
million the largest funding in the program’s history. During
the March AMSPDC annual meeting a letter was circulated for
the department chairs to sign supporting funding for the
CHGME. This effort, for the 10th year, is coordinated by the
NACH through the PPC staff. ECONOMIC RECOVERY On February 13, 2009, the House and Senate passed the $787 billion American Recovery and Reinvestment Act of 2009 (ARRA). The law provides a combination of new spending and tax cuts to states, communities, and families in an effort to stimulate the failing economy. In the House the vote was 246 - 183 with no Republicans voting in favor of the bill. In the Senate, the final vote was 60 to 38, with three Republicans - Senators Susan Collins (R-ME), Olympia Snowe (R-ME) and Arlen Specter (R-PA) - joining all of the Democrats. The 1100-page stimulus plan includes an investment in, support for, and increased funding for several programs and activities important to children and families. These include:
The Public Policy Council was very involved in lobbying with other health and medical organizations in insuring that research and health related programs were adequately addressed in the stimulus bill. On February 17th President Obama signed the recovery package into law – P.L. 111-5. Agencies will have 60 days to present spending plans to the White House, and once allotted, the spending of the supplement funding must be completed by September 30, 2010. The allocation of the economic stimulus funding can be followed at www.recovery.gov. FY 2010 BUDGET/FY 2009 OMNIBUS SPENDING BILL FY 2010 Budget – President’s Overview: Facing a deficit of over $1.75 trillion, the detailed FY 2010 Budget proposal of the Obama-Biden Administration is schedule to be introduced in May. The overview of the fiscal year budget – A New Era of Responsibility – Renewing America’s Promise - was released on February 26. It did not have in-depth details but it did outline the policy priorities of the new president. The budget overview assumes $675 billion in non-defense discretionary spending, including $78.7 billion for the Department of Health and Human Services, a 1.7 percent decrease ($1.4 billion) below the FY 2009 comparable estimate. The economic stimulus bill provides an additional $22.4 billion in FY 2009 and FY 2010 spending. There are several items of interest to the pediatric academic community that are highlighted in the budget overview: $6 billion for cancer research at the NIH, “as past of the Administration’s multi-year commitment to double cancer research funding.” The budget overview “expands research comparing the effectiveness of medical treatments.” This provision builds on the $1.1 billion comparative effectiveness research included in the economic stimulus package. The budget overview includes funding to expand “support for individuals, families, and communities affected by Autism Spectrum Disorders (ASD).” The budget includes $211 million in HHS for “research into the causes of and treatment for ASD, screening, public awareness, and support services.” There is $330 million included “to address the shortage of health care providers in certain areas.” It refers to loan repayment programs for physicians and other health professionals serving in underserved areas, nursing school capacity, and dental workforce development grants. Guided by eight principles, the Obama-Biden Administration budget overview also establishes a $634 billion reserve fund (over 10 years) to finance certain “reforms to our health care system.” The principles are:
The reserve fund is partially financed ($316 billion over 10 years) by: reducing Medicare overpayments to private insurers through competitive payments, reducing drug prices, improving Medicare and Medicaid payment accuracy, improving care after hospitalizations and reduce hospital admissions rates, expanding the hospital quality improvement program, reforming the physician payment system to improve quality and efficiency and reducing itemized deduction rate for families with incomes over $250,000. FY 2010 Congressional Concurrent Budget Resolution: Both the House and Senate Budget Committees’ introduced their version of the FY 2010 budget concurrent resolution on March 25 and both plan to begin floor debate on their respective versions the week of March 30. The congressional concurrent budget resolution is essentially an internal congressional document, non-binding on other committees and does not need to be signed by the President. The Budget Resolution however, does offer an important spending blueprint and sets in motion the process in which decisions on spending and taxes must be made – Appropriations and Reconciliation respectively. On March 25, 2009, the House Budget Committee on a party line vote of 24 – 15, passed its $3.6 trillion version of the budget resolution for FY 2010. The House Budget Committee will now prepare their resolution for what is sure to be a contentions House floor debate. House Budget Committee Chairman John Spratt’s (D-SC) FY 2010 budget proposal includes cutting the deficit in half in four years (2013), includes energy and education investments as well as reconciliation instructions health care reform as requested by President Obama. On March 26, the Senate budget resolution introduced by Chairman Kent Conrad (D-SD) was approved on a party-line vote of 13 – 10. The senate proposes cutting the deficit in half by 2012 and by two-thirds by 2014. It also addresses the priorities of President Obama including energy, education and health reform. It also includes tax relief for the middle class, and includes additional funding for the war costs. It is anticipated that the Senate floor debate will be very difficult. FY 2009 Appropriations – Omnibus Spending Bill [through September 30, 2009] Despite aggressive advocacy efforts including the efforts of the Public Policy Council, Congress was unable to complete its work on all 12 funding bills including the FY 2009 Labor-HHS-Education appropriations bill at the end of the 110th Congress. Instead Congress passed and President Bush signed a continuing resolution (CR) – a short-term spending bill - that provided funding for the nine remaining federal government agencies through March 6, 2009. Needing a few extra days to complete its work, Congress passed and the President signed a second CR until March 11, at which time the final FY 2009 omnibus spending bill was passed and signed by President Obama. The omnibus bill includes the following funding levels of interest to the Public Policy Council:
CHILDREN’S HEALTH INSURANCE PROGRAM/ACCESS TO HEALTH CARE On January 29th, the Senate voted 66-32, to approve the Child Health Insurance Program (CHIP) legislation. The bipartisan legislation preserves the health coverage of 7 million children and extends it to 4 million uninsured children who are currently eligible for, but not enrolled in SCHIP and Medicaid. The measure, which increases CHIP spending by $32.8 billion over the four-and-one-half-year period, is funded by a 62-cent-per-pack increase in the federal cigarette tax, and expands coverage to an additional four million children by 2013. No Senate Democrats voted against the bill, and nine Republicans, including Senators Snowe, Collins, Specter, Lugar, Corker, Alexander, Murkowski, Hutchison, and Martinez, voted in favor of the legislation. Following the Senate vote Speaker Pelosi and House Majority Leader Hoyer said that because the House and Senate versions of the bill were so similar, the House would clear the Senate bill and send it to President Obama without holding a conference on the legislation. On February 4th the House passed CHIP by a vote of 290-135, with 40 Republicans joining almost all Democrats in approving it. The same day President Obama signed the legislation into law. During the signing ceremony the President called the bill “a down payment” on his pledge to provide health insurance coverage to all Americans and said the reauthorization is particularly urgent because of the deepening economic crisis. Working closely with the American Academy of Pediatrics throughout this short three week process of the new Administration, the Public Policy Council members were significantly engaged on multiple advocacy levels to get this important legislation passed and signed by the President. In addition to the great success of CHIP reauthorization, on February 4th President Obama sent an official Presidential memo to the Department of Health and Human Services calling on the Secretary to rescind the August 17th directive. The directive, issued by the Centers for Medicare & Medicaid Services on August 17, 2007, in a letter to state officials, would have required states to enroll 95 percent of children from families with incomes below 200 percent of the federal poverty level before expanding coverage to those above 250 percent of the FPL. Federal Medical Assistance Program: Under the stimulus package, states will not face any scheduled reduction in the FMAP through 2011; they will receive a minimum 6.2% increase in their FMAP rate for spending October 1, 2008 to December 31, 2010; and this increased FMAP will be adjusted based on increased state numbers of the unemployed. States are required, however, to ensure that their Medicaid eligibility and enrollment/renewal procedures are no more restrictive than they were on July 1, 2008 in order to receive the increased payment. In addition, states must ensure compliance with prompt payment requirements. As states must meet with these requirements to receive the increased FMAP, states now have a very strong incentive not to cut eligibility or slow physician payment. Medicaid Moratorium: In addition to the Medicaid FMAP increase, the bill includes a new moratorium on some of the Medicaid regulations promulgated by the Bush Administration. (On June 30, 2008, President Bush signed the 2008 defense supplemental into law which included a moratorium on six Medicaid regulations through April 1, 2009.) The moratorium in the economic recovery package does and does not include the following provisions:
MEDIKIDS On January 6th, the first day of the 111th Congress, Congressman Pete Stark (D-CA), Chair Health Subcommittee of the Ways and Means Committee, reintroduced the MediKids Health Insurance Act. The bill, HR 194, was updated to include a new quality section similar to the robust quality section included in the SCHIP reauthorization legislation. Chairman Stark has repeatedly emphasized the importance of access to care for all children and looks forward to working with President-elect Obama to achieve his goal of covering all children. FDA TOBACCO BILLAlthough the legislation did not become law in the 110th Congress, the bill to give FDA strong regulatory authority over tobacco made historic progress. The House passed the bill, the Family Smoking Prevention and Tobacco Control Act (H.R. 1108/S. 625), for the first time ever. It was not taken up in the Senate although it did have 57 cosponsors. Prospects for passage in the 111th Congress look very favorable. President Obama is a strong supporter of the bill. The bill’s lead sponsor in the House, Rep. Henry Waxman (D-CA), is now chair of the powerful Energy and Commerce Committee. He reintroduced the Family Smoking Prevention and Tobacco Control Act (HR 1256) on March 3, 2009, with over 120 cosponsors; it now has 178 cosponsors. This legislation will provide the FDA with broad new authority and resources to regulate the manufacture, marketing, labeling, distribution and sale of tobacco products, including advertising. The marketing provisions include banning advertising near schools and tobacco sponsorship of sporting events. The bill would require tobacco company disclosure of cigarette constituents as well as larger and stronger health warnings on cigarette packs. It would also give the FDA the authority to regulate the amount of nicotine in cigarettes, ban flavored cigarettes, and prevent the marketing of products labeled as “reduced harm.” This enhanced power can reduce tobacco use by adolescents and young adults, thus limiting the number of people exposed to tobacco's health-compromising and life-threatening risks. At the time of this writing, the bill is tentatively scheduled to go to the House floor the week of March 30. ******************* 2009 CONGRESSIONAL CALENDAR (111th Congress –First Session)
January 19 Martin
Luther King, Jr. Holiday
2009 PEDIATRIC ACADEMIC SOCIETIES ANNUAL MEETING Three outstanding scientific sessions have been scheduled. Saturday -May 2, 2009 – 3:15 p.m. Convention Center: Celebrating its 15th collaborative year, the Public Policy Council (APS, SPR, AMSPDC) will join with the APA's Public Policy & Advocacy Committee to convene a major public policy plenary symposium entitled Personalized Medicine: Social & Ethical Issues in Screening for Genetic Disease and Susceptibility. In an era of personalized and individualized medicine, this state of the art plenary session will contemplate its implications for pediatrics such as testing for genetic diseases i.e., newborn screening. Among the topics and questions the speakers will address are testing for genetic susceptibility, false positive screenings, what are the ethical considerations, should screening be voluntary or mandatory and what is the impact of parents opting out of newborn screening. This session also will examine implications of genetic variations that are associated with increased susceptibility to common disorders with multi-factorial causation. Speakers for this outstanding session are: Ed McCabe, MD, PhD, Mattel, Children’s Hospital of UCLA, Alan Guttmacher, MD, National Human Genome Research Institute/National Institutes of Health, and Jeffrey Botkin, MD, University of Utah. The PPC chair, Myron Genel, MD, Yale University, will moderate this session. Prior to the meeting, background reading materials on personalized medicine will be posted at www.aps-spr.org Monday - May 4, 2009 – 7:00 a.m. – Convention Center: Expanding Health Care Coverage for all Children and Adolescents in the 111th Congress: Having achieved reauthorization of the state Child Health Insurance Program (CHIP) within the first two weeks of the Obama-Biden Administration, attention is now focused on the more difficult task of securing comprehensive health care reform. This session will update participants on specific features of the CHIP reauthorization, including funding for development and measurement of quality standards as well as ongoing efforts to ensure that children’s health issues are embedded in whatever comprehensive health system reform emerges from the current ferment in Washington. Speakers are: Jay Berkelhamer, MD, Children’s Health Care of Atlanta, Atlanta, GA (confirmed) and Peter Szilagyi, MD, University of Rochester, Rochester, NY (invited respondent). Monday - May 4 – 12 noon – Convention Center: For the fifth year An Update on the National Children’s Study will be provided during the PAS meeting. Participants include Drs. Ruth Brenner (NCS scientific update), Leo Trasande (urban focus), and Emanuel Walter, Jr. (rural focus). SPR president, Elena Fuentes-Afflick, MD, MPH has convened this session. ************ PUBLIC POLICY COUNCIL MEMBERS 2008 - 2009APS Myron Genel,
MD (Chair); Jimmy Simon, MD ACADEMIC PEDIATRIC ASSOCIATION PUBLIC POLICY AND ADVOCACY COMMITTEEMark Schuster, MD, PhD, Chair FOR ADDITIONAL INFORMATION CONTACT: Karen M. Hendricks, JD, Washington
Coordinator (khendricks@aap.org)
April 1, 2009 |
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the Society for Pediatric Research unless otherwise noted. Duplication of any information contained herein for reasons other than personal use requires the expressed written permission of APS / SPR. Last Updated: 05/18/2009 |
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